A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial)

Phase 2Not Yet RecruitingNCT07766005

Spyre Therapeutics, Inc.150 enrolled

Overview

This Phase 2 study will test whether the investigational medicine, SPY072, improves hidradenitis suppurativa (HS) in adults with moderate to severe disease receiving advanced standard of care treatment. About 150 participants will be assigned by chance to receive either SPY072 or placebo for 16 weeks. Participants will be followed after the treatment period to evaluate safety and how long treatment effects may last.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, proof-of-concept study of SPY072 in adults 18 to 75 years of age with moderate to severe HS who are receiving advanced standard of care treatment. After a screening period, approximately 150 eligible participants will be randomized to SPY072 or matching placebo through Week 16. After completion of treatment, participants will then enter a follow-up period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Hidradenitis Suppurativa (HS)

Interventions

SPY072DRUG

Solution for SC injection

PlaceboDRUG

Matching placebo for SC injection

bimekizumabDRUG

Advanced standard of care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of Hidradenitis Suppurativa with symptoms for at least 6 months before screening. * Hidradenitis suppurativa lesions in at least 2 distinct anatomical areas, with at least 1 area meeting Hurley Stage II or III criteria at screening and Day 1. * Total abscess and/or inflammatory nodule count of at least 5 at screening and Day 1. * Documented inadequate response, intolerance, or contraindication to at least 1 systemic therapy for hidradenitis suppurativa. Exclusion Criteria: * More than 20 draining tunnels at screening or Day 1. * Hidradenitis suppurativa lesion expected to require incision and drainage within 4 weeks before Day 1, or major hidradenitis suppurativa surgery within 12 weeks before Day 1. * Another inflammatory or skin condition that could interfere with assessment of hidradenitis suppurativa.

Locations (12)

Site 111

Irvine, California, United States

Site 101

Indianapolis, Indiana, United States

Site 100

Bowling Green, Kentucky, United States

Outcomes

Primary Outcomes

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

HiSCR75 is defined as at least a 75% reduction from baseline in total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining tunnel count

Time frame: Week 16

Secondary Outcomes

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

HiSCR50 is defined as at least a 50% reduction from baseline in total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining tunnel count.

Time frame: Week 16

Treatment-emergent Adverse Events (TEAEs)

Incidence, severity and causal relationship of TEAEs

Time frame: Up to 52 weeks

Central Contacts

SKYLIGHT Trial Center

CONTACT

1-702-602-7976 info@SKYLIGHT-trial.com

Data from ClinicalTrials.gov

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